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Study to Evaluate the Efficacy and Safety of 90Y-SMT487 in Subjects With Symptomatic Malignant Carcinoid Tumors

This study has been completed.
Study NCT00696930.   Last updated on June 12, 2008.   Information provided by Molecular Insight Pharmaceuticals, Inc.

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Descriptive Information Fields
Brief Title  Study to Evaluate the Efficacy and Safety of 90Y-SMT487 in Subjects With Symptomatic Malignant Carcinoid Tumors
Official Title  A Phase II Open-Label Multi-Center Study to Evaluate the Efficacy and Safety of 90Y-SMT487 in Subjects With Symptomatic Malignant Carcinoid Tumors
Brief Summary

Subjects will be screened to determine OctreoScan® uptake. And upon meeting the eligibility criteria, 90 subjects will complete a symptom assessment scale at baseline and throughout the study at specific time points. Actual treatment will consist of three six-week cycles of a fixed total dose of 13.3 GBq (360 mCi) of 90Y-SMT487. The total dose will be divided into three equal doses and administered as a single activity of 4.4 GBq (120 mCi) of 90Y-SMT487 once every six weeks for three cycles. An amino acid infusion will be administered along with each dose. Long-term follow up will occur at 6 and 12 months after Day 1/ Cycle 1. Survival will be assessed every six months.

Detailed Description
Study Phase Phase II
Study Type  Interventional
Study Design  Treatment, Safety/Efficacy Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Malignant Carcinoid Tumor
Intervention  Drug: 90Y-SMT487
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date 
Completion Date
Eligibility Criteria 

Inclusion Criteria:

  1. Life expectancy > 6 months.
  2. Subjects must have distant metastases.
  3. Subjects must be able to discontinue Sandostatin LAR treatment for at least 1 month prior to Day 1/Cycle 1; last dose of Sandostatin LAR must be 60 days or more prior to the first OctreoTher™ dose. For subcutaneous Sandostatin discontinuation should be 12 hours. Subjects taking other long acting somatostatin analogues must discontinue the analogue at least 2 times the dosing interval.
  4. Upon baseline disease assessment, all subjects must have at least 1 measurable site of disease that either has never been irradiated or if the measurable lesion has been previously irradiated; this same lesion has since demonstrated progression base don the SWOG response criteria.
  5. Subjects must state or agree with the statement that "I have symptoms from my cancer that bother me." Subjects must have failed to gain complete symptom control despite an optimal attempt at somatostatin therapy in the judgement of their physician.

Exclusion Criteria:

  1. Chemotherapy, biologic therapy or other investigational therapy within 4 weeks of Day 1.
  2. Surgery, hormonal therapy (not including somatostatin analogues) or radiation, within 2 weeks of Day 1.
  3. Subjects with know brain metastases unless these metastases have been treated and stabilized for at least six months prior to study start.
  4. Subjects who received high dose OctreoScan therapy or other radiolabelled somatostatin therapy or other systemic radiolabelled therapy (e.g. MIBG) for treatment of metastatic carcinoid.
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries 
Administrative Information Fields
NCT ID  NCT00696930
Organization ID CSMT 487A 2202
Secondary IDs ††
Study Sponsor  Molecular Insight Pharmaceuticals, Inc.
Collaborators ††
Investigators 
Information Provided By Molecular Insight Pharmaceuticals, Inc.
Verification Date June 2008
First Received Date  June 11, 2008
Last Updated Date June 12, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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